510(k) · Cleared
ClearedCardiologs Holter Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips France Commercial · DPS Electrocardiograph
Cleared on Aug 6, 2025 as substantially equivalent to K212112 (Cardiologs Technologies, 2021) after a 161-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Aug 6, 2025
- Review
- 161 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003621 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 5 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 4 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 3 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 2 generations backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- 1 generation backK212112 Cardiologs Holter PlatformCardiologs Technologies · 2021
- This deviceK250569 Cardiologs Holter PlatformPhilips France Commercial · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −5 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −4 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −3 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −2 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| −1 | K212112 | Cardiologs Holter Platform | Cardiologs Technologies | 2021 | — |
| 0 (this device) | K250569 | Cardiologs Holter Platform | Philips France Commercial | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212112 | Cardiologs Holter PlatformSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K212112 11 Cardiologs Holter Platform… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K212112.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices indicated for recording heart rhythm. The Cardiologs…
Read the full statement (213 words)
The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population.
The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices indicated for recording heart rhythm.
The Cardiologs Holter Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.
The Cardiologs Holter Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis. The Cardiologs Holter Platform is not for use in life supporting or sustaining systems or ECG monitor and physiological alarm devices.
The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
Cardiologs Holter Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns patient backoround. clinical history symptoms and other diaonostic information.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250569: Cardiologs Holter Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250569
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026